JP4921549B2 - Improvement of dry powder inhaler - Google Patents

Improvement of dry powder inhaler Download PDF

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Publication number
JP4921549B2
JP4921549B2 JP2009508513A JP2009508513A JP4921549B2 JP 4921549 B2 JP4921549 B2 JP 4921549B2 JP 2009508513 A JP2009508513 A JP 2009508513A JP 2009508513 A JP2009508513 A JP 2009508513A JP 4921549 B2 JP4921549 B2 JP 4921549B2
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JP
Japan
Prior art keywords
mouthpiece
opening
blister
cylinder
strip
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
JP2009508513A
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Japanese (ja)
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JP2009536062A (en
Inventor
ペンタフラガス、ディミトリオス
Original Assignee
ペンタフラガス、ディミトリオス
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to GR20060100276 priority Critical
Priority to GR20060100276A priority patent/GR1005620B/en
Application filed by ペンタフラガス、ディミトリオス filed Critical ペンタフラガス、ディミトリオス
Priority to PCT/GR2007/000027 priority patent/WO2007129128A1/en
Publication of JP2009536062A publication Critical patent/JP2009536062A/en
Application granted granted Critical
Publication of JP4921549B2 publication Critical patent/JP4921549B2/en
Application status is Expired - Fee Related legal-status Critical
Anticipated expiration legal-status Critical

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0028Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0001Details of inhalators; Constructional features thereof
    • A61M15/002Details of inhalators; Constructional features thereof with air flow regulating means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0001Details of inhalators; Constructional features thereof
    • A61M15/0021Mouthpieces therefor
    • A61M15/0025Mouthpieces therefor with caps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00Inhalators
    • A61M15/0028Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
    • A61M15/003Inhalators using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up using capsules, e.g. to be perforated or broken-up
    • A61M15/0043Non-destructive separation of the package, e.g. peeling

Description

  The present invention relates to a device for inhaling a medicament in the form of a dry powder, packaged in a blister of a single dose blister strip.

  The administration of pharmaceuticals by inhalation is one of the most reliable approaches in therapy that can be applied to a wide variety of diseases. Although the first inhalable medicines were used to treat diseases affecting the respiratory tract, recently there has been increasing interest in developing inhaled forms of drugs that target a variety of other diseases such as diabetes.

  Administration of pharmaceuticals by inhalation is performed using an inhalation device (inhaler). A number of such devices are included in the state of the art. Many types of inhalers have pharmaceuticals placed in the receptacle in the form of dry powder, creating a flow of air that the patient uses the power of the lungs to carry the powder, and then the powder is inhaled through the mouthpiece, Includes inhaler. These devices are known as dry powder inhalers (DPI). The powder in the device is placed in a container and the required amount is metered therefrom using an internal mechanism or packed as a separate dose in a corresponding receptacle, such as a blister pack or capsule. Powders contain the active ingredients, most often in combination with one or more excipients.

  International patent application WO03082389 discloses a dry powder inhaler in which the medicament is stored in a blister of a specially designed single dose blister strip. The apparatus includes a mouthpiece, a blister strip support surface, and a strip storage compartment. The strip support surface includes attachment points (eg, protrusions), cavities that receive the blisters of the strip, and guides for properly aligning and stably positioning the strip. The mouthpiece is placed on the support surface so that when the blister strip is placed on the support surface and the mouthpiece is in its basic position, the base of the mouthpiece contacts the strip and completely covers the powder-containing blister. It is joined so that it can move.

  The mouthpiece of the device comprises three parts: an outer part and two conical inner parts. The first internal part, which has two openings on the lower side and contacts the blister of the strip, is divided into two chambers through which the air entering the mouthpiece carries the powder. The mixture of air and powder then passes through the second internal part of the mouthpiece and exits the device.

  The mouthpiece of the device described above functions satisfactorily, but can improve several points. First of all, due to the mouthpiece design, the resistance of the device is very high. The resistance of the device corresponds to the force that the patient must inhale to accept the medication. It is desirable that the resistance of the device is not very high so that a wide variety of patients can use the device. Furthermore, when the device is used, a small amount of powder accumulates in the inner wall of the mouthpiece. The amount of powder is so small that it does not affect the therapeutic effectiveness of the device, but if accumulation occurs, this accumulation will cause problems after prolonged use, as the device must be cleaned. There is a fear.

  The present invention solves the above-mentioned problems by providing on the one hand the possibility of reducing the resistance of the device and on the other hand eliminating the possibility of powder accumulation inside the mouthpiece.

  The present invention provides a mouthpiece suitable for use with the device disclosed in international patent application WO03082389. The base of the mouthpiece according to the invention is arranged directly above and in contact with the powder-containing blister of the strip. The dimension of the base of the mouthpiece is such that it completely covers the powder containing blister.

  The mouthpiece comprises three main parts, the first is an external part that the patient places in the mouth during inhalation, and the other two are internal parts that are fixed over each other. The upper part is generally conical and its top constitutes the mouthpiece outlet and its base is fixed at the top of the lower part. The lower part comprises at least one opening for allowing inhaled air into the interior and two other openings at the base, the base of the mouthpiece contacting the powder containing blister Corresponds to the base. The first of the two openings corresponds to the air inlet into the blister and the second corresponds to the powder outlet from the blister. According to the invention, the powder outlet from the blister is also a cylindrical base, positioned in a substantially vertical orientation with respect to the mouthpiece base, the height of the cylinder being equal to the height of the lower part of the mouthpiece. At least the same. The height of the cylinder depends on the characteristics of each powder, and its top may reach the exit of the mouthpiece. It is generally preferred that the height of the cylinder is such that its top does not exceed 50% of the height of the upper part of the mouthpiece. It is particularly preferred that the top of each cylinder does not exceed 20% of the height of the upper part of the mouthpiece, and even more preferred that the top of each cylinder does not exceed 10% of said height. The top part of the lower part of the mouthpiece is sealed by a cover having an opening, and the cylinder passes through the opening. According to the present invention, the size of the opening is larger than the diameter of the cylinder. The gap between the opening of the cover and the cylinder is such that some of the air entering the lower part of the mouthpiece passes through the gap instead of traveling towards the powder-containing blister and passes through the upper part of the mouthpiece. Allows you to get out of the piece. The size of the gap depends on the characteristics of each powder and the group of patients using the device. It is generally preferred that the entire surface of the gap should be at most three times the surface of the opening (s) for introducing air into the lower part of the mouthpiece. More preferably, the surface of the gap should be at most twice as large as the surface of the air opening (s), and the surface of the gap should be at most within the lower part of the mouthpiece It is particularly preferred that it should be 1.5 times as large as the surface of the air opening (s) for entraining air.

  The mouthpiece disclosed herein has significant advantages compared to the mouthpiece disclosed in international patent application WO03082389. As mentioned above, in the mouthpiece of the international patent application WO03082389, the total amount of air entering the mouthpiece passes through the two openings in its base, thereby creating a relatively high resistance of the device. In the present invention, when a part of the air passes through the gap between the opening of the cover of the lower part of the mouthpiece and the cylinder, a part of the pressure generated in the air entering the lower part of the mouthpiece is Since released, the presence of the gap reduces the resistance of the device. Thus, the air flow, ie the amount of air that passes through the device within a unit time, is increased, thus reducing the resistance of the device. In addition, the resistance can be easily corrected by changing the size of the opening in the cover without changing the remaining parts of the mouthpiece, which makes the device of the present invention cost effective and simple. This means that it can be manufactured and modified. The resistance of the device can vary depending on the medication being administered or the group of patients using the device. Furthermore, the present invention eliminates the possibility of powder accumulation within the inner wall of the mouthpiece.

  The mouthpiece of the present invention can be used with the device disclosed in International Patent Application WO03082389. That is, another aspect of the present invention is a dry powder inhalation device in which powder is packaged in a blister of a single dose blister strip, the device comprising a mouthpiece as described above, a strip support surface, A strip storage compartment. The support surface includes an attachment point, a cavity for receiving the blister of the strip, and a guide for correctly aligning and stably positioning the blister strip. The attachment point is preferably a protrusion. The mouthpiece is movably joined to the strip support surface so that the mouthpiece base contacts the strip and completely covers the powder-containing blister when the device is ready for inhalation.

  The single dose blister strip comprises a base sheet and a cover sheet. The base sheet includes a powder containing blister and an attachment configuration. The mounting configuration is preferably a hole. The base sheet is sealed by a cover sheet in the area around the blister, and the free end of the cover sheet initially covers the mounting configuration but is folded 180 ° to create a pull tab, the pull tab Allows the user to expose the powder by peeling the cover sheet off the base sheet. The active pharmaceutical ingredients packaged in the strip blisters can be used as is or can be combined with suitable excipients. Accordingly, the term pharmaceutical refers to either the intact pharmaceutical ingredient or a combination thereof with suitable excipients throughout the specification and the appended claims.

  The apparatus of the present invention is used as follows. The user lifts the mouthpiece from its basic position and places the strip on the support surface such that the mounting configuration of the strip is combined with the mounting point of the support surface. The strip is aligned using the guide and the blister enters the cavity of the support surface. The user then returns the mouthpiece to its base position and exposes the powder by pulling off the strip cover sheet. At this point, the base of the mouthpiece contacts the strip while completely covering the powder containing blister and the device is ready for inhalation. The user then inhales the powder and then the user confirms that the user has inhaled the full dose of the drug by lifting the mouthpiece from its basic position to remove the used blister.

  FIG. 1 shows an example of the mouthpiece of the present invention. The mouthpiece comprises three main parts: an external part (1) that the patient places in the mouth during inhalation, and two internal parts, one of which is fixed on top of the other. The In this particular example, the base of the external part (1) has an opening (notch 4) through which air enters the mouthpiece. The upper internal part of the mouthpiece is a cone (2) that is fixed inside the external part (1). The top of the cone (2) corresponds to the outlet of the mouthpiece, the base of which is fixed on the top of the lower internal part (3). Said part has an opening (5) for the introduction of air and two openings (6) and (7) at its base. The opening (6) corresponds to the air inlet in the powder-containing blister, and the second opening (7) corresponds to the powder outlet from the blister. As shown in FIG. 2, the second opening (7) is also the base of the cylinder (8) and the height of the cylinder is slightly higher than the lower part (3). The top of the component (3) is sealed by a cover (9) having an opening (10), and a cylinder (8) passes through the opening (10). As clearly shown in FIG. 2, the size of the opening (10) is larger than the diameter of the cylinder (8), thus forming a gap, as will be explained below, in the lower part (3). Part of the incoming air passes through the gap. In this particular example, the three main parts of the mouthpiece are held together by the ring (11) (FIG. 1).

  FIG. 3 shows the vertical cross section of the mouthpiece of the present invention and the air flow through the mouthpiece when placed over the powder containing blister. Air enters the mouthpiece through one or more openings (not shown). The air then passes through the opening (5) and enters the lower part (3) of the mouthpiece. There, some of the air passes through the opening (6) for the air to enter the blister (18), carrying away the powder contained in the blister (18) of the strip, and the mixture of air and powder becomes It passes through the opening (7) for the powder out of the blister into the cylinder (8) and from there enters the upper part (2). The second part of the air entering the lower part passes through the opening 10 and enters the upper part 2. This air intersects with and mixes with the mixture of powder and air leaving the cylinder (8) to create a new mixture of air and powder that exits the mouthpiece through the opening (13).

  The mouthpiece of the present invention can be used with the device disclosed in International Patent Application No. WO03082389 and shown in FIG. 4, in which the medicament is packaged in a blister (FIG. 5) of a single dose blister strip. The apparatus comprises a mouthpiece (A) movably joined to a strip support surface (B), said support surface receiving a mounting point (protrusion (14) in this particular example) and a strip blister. A cavity (12) and a guide part (15) are provided. The apparatus also comprises a strip storage compartment (C).

  The single dose blister strip (FIG. 5) comprises a base sheet (16), which has a mounting configuration (in this particular example, a hole (17)), and a powder containing blister (18). Is provided. The base sheet is sealed by a cover sheet (19) in the area around the blister (18), the free end of the cover sheet (19) initially covering the hole (17) but then 180 ° It is folded to create a pull tab and allows the user to expose the powder by peeling the cover sheet (19) from the base sheet (16).

  The single dose blister strip is placed in the inhaler device as shown in FIG. That is, the user first lifts the mouthpiece from its basic position and places the strip so that the hole (17) in the strip is placed around the protrusion (14) and the blister (18) enters the cavity (12). Place on the support surface. The user then returns the mouthpiece to its basic position and pulls the cover sheet (19) until it is removed from the base sheet (16). While maintaining the mouthpiece in its basic position, the user inhaled the powder and then the user inhaled the entire dose by lifting the mouthpiece to replace the used strip Can be confirmed.

It is a figure which shows the main components of the mouthpiece of this invention. It is a figure which shows the downward part of a mouthpiece. It is a vertical cross section which shows a mouthpiece. It is a figure which shows the dry powder inhalation device by this invention. FIG. 6 shows a single dose blister strip. FIG. 5 shows how the blister strip is placed in the device.

Claims (8)

  1.   An inhalation device for administering a medicament in the form of a dry powder, packaged in a single dose blister strip blister, said device comprising a mouthpiece (A), a strip support surface (B), a strip A storage compartment (C), the mouthpiece (A) is movably joined to the support surface (B), and the mouthpiece comprises an upper internal component (2), a lower internal component (3), The lower part (3) includes at least one opening (5) for introducing air therein, an opening (6) for introducing air into the powder containing blister, and from the blister An opening (7) for dispensing powder, the support surface comprising a mounting point (14), a cavity (12) for receiving the blister of the strip, and a guide (15). The opening (7) for taking out the powder from the blister corresponds to the base of the cylinder (8), and the height of the cylinder is at least the same as the height of the lower part (3) of the mouthpiece The lower part (3) of the mouthpiece is sealed by a cover (9) having an opening (10), the cylinder (8) passes through the opening (10), A device characterized in that the size of the opening is larger than the diameter of the cylinder (8), leaving a gap between the cylinder (8) and the opening (10).
  2.   The apparatus of claim 1, wherein the attachment point is a protrusion (14).
  3.   The surface of the gap between the opening (10) of the cover (9) and the cylinder (8) is one (1) for introducing the air into the lower part (3) of the mouthpiece. Device according to claim 1 or 2, wherein the device is at most three times as large as the entire surface of the opening (s).
  4.   The apparatus of claim 3, wherein the surface of the gap is at most twice as large.
  5.   The apparatus of claim 4, wherein the surface of the gap is up to 1.5 times larger.
  6.   Device according to any of the preceding claims, wherein the height of the cylinder (8) is such that its top does not exceed 50% of the height of the upper part (2) of the mouthpiece. .
  7.   The device according to claim 6, wherein the top of the cylinder (8) does not exceed 20% of the height of the upper part (2) of the mouthpiece.
  8.   The device according to claim 7, wherein the top of the cylinder (8) does not exceed 10% of the height of the upper part (2) of the mouthpiece.
JP2009508513A 2006-05-09 2007-05-09 Improvement of dry powder inhaler Expired - Fee Related JP4921549B2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
GR20060100276 2006-05-09
GR20060100276A GR1005620B (en) 2006-05-09 2006-05-09 Improved dry powder inhaler
PCT/GR2007/000027 WO2007129128A1 (en) 2006-05-09 2007-05-09 Improvement of a dry powder inhaler

Publications (2)

Publication Number Publication Date
JP2009536062A JP2009536062A (en) 2009-10-08
JP4921549B2 true JP4921549B2 (en) 2012-04-25

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JP2009508513A Expired - Fee Related JP4921549B2 (en) 2006-05-09 2007-05-09 Improvement of dry powder inhaler

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US (1) US8037881B2 (en)
EP (1) EP2015813B1 (en)
JP (1) JP4921549B2 (en)
KR (1) KR20090005365A (en)
CN (1) CN101400397B (en)
AT (1) AT486625T (en)
AU (1) AU2007246859B2 (en)
CA (1) CA2651589C (en)
CY (1) CY1111546T1 (en)
DE (1) DE602007010277D1 (en)
DK (1) DK2015813T3 (en)
EA (1) EA013180B1 (en)
EG (1) EG25864A (en)
ES (1) ES2355392T3 (en)
GR (1) GR1005620B (en)
HK (1) HK1130713A1 (en)
HR (1) HRP20110081T1 (en)
MX (1) MX2008014295A (en)
PL (1) PL2015813T3 (en)
PT (1) PT2015813E (en)
RS (1) RS51895B (en)
SI (1) SI2015813T1 (en)
UA (1) UA92082C2 (en)
WO (1) WO2007129128A1 (en)
ZA (1) ZA200806511B (en)

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KR20080096809A (en) 2006-02-22 2008-11-03 맨카인드 코포레이션 A method for improving the pharmaceutic properties of microparticles comprising diketopiperazine and an active agent
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Also Published As

Publication number Publication date
CY1111546T1 (en) 2015-08-05
US8037881B2 (en) 2011-10-18
RS51895B (en) 2012-02-29
PL2015813T3 (en) 2011-04-29
ZA200806511B (en) 2009-05-27
HRP20110081T1 (en) 2011-03-31
GR1005620B (en) 2007-09-03
CA2651589C (en) 2012-06-19
CN101400397A (en) 2009-04-01
AT486625T (en) 2010-11-15
EA013180B1 (en) 2010-02-26
SI2015813T1 (en) 2011-03-31
DK2015813T3 (en) 2011-02-14
WO2007129128A1 (en) 2007-11-15
US20100154795A1 (en) 2010-06-24
JP2009536062A (en) 2009-10-08
CN101400397B (en) 2011-11-09
EA200870520A1 (en) 2009-02-27
PT2015813E (en) 2011-02-01
CA2651589A1 (en) 2007-11-15
EG25864A (en) 2012-09-12
AU2007246859B2 (en) 2012-11-29
ES2355392T3 (en) 2011-03-25
KR20090005365A (en) 2009-01-13
HK1130713A1 (en) 2012-09-07
EP2015813B1 (en) 2010-11-03
MX2008014295A (en) 2009-02-12
UA92082C2 (en) 2010-09-27
DE602007010277D1 (en) 2010-12-16
AU2007246859A1 (en) 2007-11-15
EP2015813A1 (en) 2009-01-21

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